Drug · FAERS side-effect profile with label screen
Betamethasone Valerate side effects: what 4,502 FDA adverse event reports show
Drug class
Medium potency topical corticosteroid
FDA label, Indications wording
Who reports
4,502 reports · 89% serious · 235 with death outcome · 67% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
FDA label, Indications and Usage
What it is
DESCRIPTION Betamethasone valerate foam, 0.12% contains betamethasone valerate, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 36
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 343 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Macular degeneration | 644 | 266.2 247.2–286.6ROR 310.5 · χ² 160,674 / p <1e-300 | 249.8 EB05 234.0 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 176.2 · ♀ 100% (drug 67%) | no trial data cached |
| Vaginal discharge | 167 | 78.7 67.8–91.5ROR 81.7 · χ² 12,530 / p <1e-300 | 76.8 EB05 67.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=167 · ♀ 100% (drug 67%) | no trial data cached |
| Paraesthesia oral | 210 | 69.1 60.5–78.9ROR 72.4 · χ² 13,819 / p <1e-300 | 67.6 EB05 60.3 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 78.9 · ♀ 97% (drug 67%) | no trial data cached |
| Oral candidiasis (oral thrush) | 184 | 66.8 57.9–77.0ROR 69.6 · χ² 11,699 / p <1e-300 | 65.4 EB05 57.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 59.9 · ♀ 98% (drug 67%) | no trial data cached |
| Taste disorder | 164 | 38.4 33.0–44.7ROR 39.8 · χ² 5,897 / p <1e-300 | 38.0 EB05 33.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 49.1 · ♀ 98% (drug 67%) | no trial data cached |
| Frequent bowel movements | 186 | 32.4 28.1–37.3ROR 33.8 · χ² 5,600 / p <1e-300 | 32.1 EB05 28.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 32.2 · ♀ 96% (drug 67%) | no trial data cached |
| Sleep disorder due to a general medical condition | 111 | 32.2 26.8–38.7ROR 33.0 · χ² 3,302 / p <1e-300 | 31.8 EB05 27.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 33.7 · ♀ 88% (drug 67%) | no trial data cached |
| Procedural pain | 186 | 31.5 27.4–36.3ROR 32.8 · χ² 5,438 / p <1e-300 | 31.2 EB05 27.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 35.0 · ♀ 100% (drug 67%) | no trial data cached |
| Flank pain | 61 | 30.6 23.8–39.2ROR 31.0 · χ² 1,704 / p <1e-300 | 30.1 EB05 24.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · ♀ 98% (drug 67%) | no trial data cached |
| Wound infection | 67 | 28.9 22.8–36.7ROR 29.3 · χ² 1,765 / p <1e-300 | 28.5 EB05 23.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.0 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Epilepsy | 175 | 26.9 23.2–31.1ROR 27.9 · χ² 4,312 / p <1e-300 | 26.6 EB05 23.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · ♀ 95% (drug 67%) | no trial data cached |
| Rectal haemorrhage | 233 | 25.3 22.3–28.7ROR 26.6 · χ² 5,396 / p <1e-300 | 25.1 EB05 22.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · ♀ 94% (drug 67%) | no trial data cached |
| Red blood cell sedimentation rate increased | 58 | 24.5 18.9–31.6ROR 24.8 · χ² 1,277 / p 7e-280 | 24.2 EB05 19.4 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 17.9 · ♀ 100% (drug 67%) · 100% clinician | no trial data cached |
| Synovitis | 93 | 24.1 19.7–29.5ROR 24.6 · χ² 2,029 / p <1e-300 | 23.9 EB05 20.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · ♀ 96% (drug 67%) | no trial data cached |
| Hypercholesterolaemia | 49 | 24.0 18.1–31.7ROR 24.2 · χ² 1,051 / p 9e-231 | 23.7 EB05 18.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · ♀ 100% (drug 67%) | no trial data cached |
| Pemphigus | 61 | 23.0 17.9–29.5ROR 23.3 · χ² 1,254 / p 6e-275 | 22.7 EB05 18.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 100% (drug 67%) | no trial data cached |
| Colitis | 183 | 22.7 19.7–26.2ROR 23.7 · χ² 3,769 / p <1e-300 | 22.6 EB05 20.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 · ♀ 97% (drug 67%) | no trial data cached |
| Colitis ulcerative | 191 | 20.0 17.4–23.0ROR 20.9 · χ² 3,426 / p <1e-300 | 19.9 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · ♀ 96% (drug 67%) | no trial data cached |
| Haematochezia (blood in stool) | 214 | 18.2 15.9–20.7ROR 19.0 · χ² 3,447 / p <1e-300 | 18.1 EB05 16.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 95% (drug 67%) | no trial data cached |
| Therapeutic product effect incomplete | 274 | 18.1 16.1–20.3ROR 19.2 · χ² 4,411 / p <1e-300 | 18.0 EB05 16.3 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 21.5 · ♀ 95% (drug 67%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 247 | 17.5 15.5–19.7ROR 18.4 · χ² 3,818 / p <1e-300 | 17.4 EB05 15.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 · ♀ 96% (drug 67%) | no trial data cached |
| Folliculitis | 35 | 15.8 11.4–22.0ROR 15.9 · χ² 470 / p 1e-104 | 15.6 EB05 11.6 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · ♀ 100% (drug 67%) · 94% clinician | no trial data cached |
| Diabetes mellitus inadequate control | 56 | 14.8 11.4–19.2ROR 14.9 · χ² 704 / p 2e-155 | 14.6 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 96% (drug 67%) · 90% clinician | no trial data cached |
| Bursitis | 38 | 14.7 10.7–20.2ROR 14.8 · χ² 471 / p 1e-104 | 14.4 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 100% (drug 67%) · 97% clinician | no trial data cached |
| Laryngitis | 34 | 14.6 10.5–20.5ROR 14.7 · χ² 417 / p 5e-93 | 14.3 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 100% (drug 67%) · 94% clinician | no trial data cached |
| Foot deformity | 32 | 13.5 9.5–19.0ROR 13.6 · χ² 356 / p 1e-79 | 13.1 EB05 9.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 100% (drug 67%) | no trial data cached |
| Sciatica | 45 | 13.2 9.9–17.7ROR 13.4 · χ² 496 / p 3e-110 | 13.0 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · ♀ 100% (drug 67%) · 100% clinician | no trial data cached |
| Pericarditis | 46 | 12.9 9.7–17.2ROR 13.0 · χ² 492 / p 3e-109 | 12.6 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Depressed mood | 145 | 12.9 11.0–15.1ROR 13.3 · χ² 1,574 / p <1e-300 | 12.8 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 89% (drug 67%) | no trial data cached |
| Angina pectoris | 79 | 12.8 10.3–15.9ROR 13.0 · χ² 845 / p 4e-186 | 12.6 EB05 10.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 97% (drug 67%) | no trial data cached |
| Gait inability | 89 | 12.6 10.2–15.4ROR 12.8 · χ² 934 / p 2e-205 | 12.4 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 92% (drug 67%) | no trial data cached |
| Back injury | 29 | 12.5 8.7–18.0ROR 12.6 · χ² 295 / p 2e-66 | 12.0 EB05 8.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | no trial data cached |
| Wound | 73 | 12.3 9.8–15.4ROR 12.4 · χ² 743 / p 8e-164 | 12.1 EB05 9.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Wheezing | 155 | 12.2 10.5–14.3ROR 12.6 · χ² 1,588 / p <1e-300 | 12.1 EB05 10.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 95% (drug 67%) | no trial data cached |
| Dyspepsia (indigestion) | 252 | 12.0 10.6–13.5ROR 12.6 · χ² 2,533 / p <1e-300 | 11.9 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 94% (drug 67%) | no trial data cached |
| Autoimmune disorder | 23 | 11.2 7.5–16.9ROR 11.3 · χ² 204 / p 2e-46 | 10.4 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 109 | 11.0 9.2–13.3ROR 11.3 · χ² 983 / p 4e-216 | 10.9 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 94% (drug 67%) | no trial data cached |
| Migraine | 223 | 11.0 9.7–12.5ROR 11.5 · χ² 2,015 / p <1e-300 | 10.9 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · ♀ 96% (drug 67%) | no trial data cached |
| Joint range of motion decreased | 31 | 10.8 7.6–15.4ROR 10.9 · χ² 266 / p 4e-60 | 10.2 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 100% (drug 67%) · 97% clinician | no trial data cached |
| Lower respiratory tract infection | 105 | 10.8 8.9–13.1ROR 11.0 · χ² 925 / p 2e-203 | 10.6 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 96% (drug 67%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,066 | 3.8 3.6–4.0ROR 4.6 · χ² 2,314 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · ♀ 92% (drug 67%) | no trial data cached |
| Macular degeneration | 644 | 266.2 247.2–286.6ROR 310.5 · χ² 160,674 / p <1e-300 | 249.8 EB05 234.0 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 176.2 · ♀ 100% (drug 67%) | no trial data cached |
| Pain | 602 | 4.6 4.2–4.9ROR 5.1 · χ² 1,719 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 91% (drug 67%) | no trial data cached |
| Off label use (used outside approved label) | 487 | 2.6 2.4–2.8ROR 2.8 · χ² 505 / p 5e-112 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · ♀ 90% (drug 67%) | no trial data cached |
| Malaise (feeling unwell) | 420 | 4.5 4.1–4.9ROR 4.8 · χ² 1,144 / p 4e-251 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 87% (drug 67%) | no trial data cached |
| Nausea | 419 | 2.5 2.3–2.7ROR 2.6 · χ² 381 / p 4e-85 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · ♀ 87% (drug 67%) | no trial data cached |
| Pyrexia (fever) | 419 | 5.6 5.2–6.2ROR 6.1 · χ² 1,621 / p <1e-300 | 5.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 88% (drug 67%) | no trial data cached |
| Weight decreased (weight loss) | 411 | 6.9 6.3–7.5ROR 7.5 · χ² 2,080 / p <1e-300 | 6.8 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 94% (drug 67%) | no trial data cached |
| Headache | 407 | 3.0 2.8–3.3ROR 3.2 · χ² 568 / p 9e-126 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · ♀ 90% (drug 67%) | no trial data cached |
| Pruritus (itching) | 347 | 4.3 3.9–4.7ROR 4.6 · χ² 884 / p 2e-194 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Rash | 324 | 3.5 3.1–3.9ROR 3.7 · χ² 582 / p 6e-129 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Erythema (skin redness) | 306 | 7.0 6.2–7.7ROR 7.4 · χ² 1,566 / p <1e-300 | 6.9 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 87% (drug 67%) | no trial data cached |
| Abdominal pain | 301 | 6.0 5.4–6.7ROR 6.4 · χ² 1,272 / p 6e-279 | 6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 88% (drug 67%) | no trial data cached |
| Vomiting | 295 | 2.9 2.6–3.3ROR 3.1 · χ² 382 / p 2e-85 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · ♀ 90% (drug 67%) | no trial data cached |
| Dyspnoea (shortness of breath) | 293 | 2.4 2.2–2.7ROR 2.5 · χ² 248 / p 4e-56 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Macular degeneration — n=644, PRR 266.2
- Vaginal discharge — n=167, PRR 78.7
- Oral candidiasis — n=184, PRR 66.8
- Taste disorder — n=164, PRR 38.4
- Frequent bowel movements — n=186, PRR 32.4
- Sleep disorder due to a general medical condition — n=111, PRR 32.2
- Procedural pain — n=186, PRR 31.5
- Flank pain — n=61, PRR 30.6
- Wound infection — n=67, PRR 28.9
- Epilepsy — n=175, PRR 26.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Betamethasone Valerate?
In FDA FAERS, the most frequently co-reported reaction terms for Betamethasone Valerate are macular degeneration, pain, malaise, nausea, pyrexia, weight decreased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Betamethasone Valerate have an FDA boxed warning?
No. The FDA label retrieved for Betamethasone Valerate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Betamethasone Valerate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 3b6fa573-de04-4626-a39a-dca39def6df2, effective 20240823; matched on
openfda.generic_name.exact:"BETAMETHASONE VALERATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 383 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.